An observational study in Glaucoma, Glaucoma Eye and Glaucoma, Open-Angle, sponsored by Imperial College Healthcare NHS Trust. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-28.
Sponsored by Imperial College Healthcare NHS Trust · Observational
This Prospective Interventional Study will assess the efficacy of MPTLT in the UK.
We are establishing a National Study of MPTLT procedures, co-ordinating with all UK treatment centres to capture prospectively, details of all MPTLT surgical procedure and outcomes. This will create a National UK Registry of MPTLT, allowing us to comply with NICE requirements while adding to the quality of evidence available to support this minimally invasive therapy.
1,419 studies on the registry are indexed under Glaucoma; 223 are open to participants now.
This study's planned enrollment of 250 is above the median of 101 across 385 observational studies indexed under Glaucoma.
Browse Glaucoma studies →Imperial College Healthcare NHS Trust is the lead sponsor of 80 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
UK patients with glaucoma or ocular hypertension deemed clinically suitable for MPTLT treatment by their treating ophthalmologist
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All UK patients undergoing MPTLT
Device: Micropulse Transscleral laser therapy
Transscleral laser cyclophotocoagulation using the IRIDEX Cyclo G6 machine
Also known as: Cyclophotocoagulation, IRIDEX Cyclo G6
Change in intra-ocular pressure (IOP) following treatment
Change in mean IOP before and after treatment, measured in mmHg using Goldmann Applanation Tonometry
Time frame: At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36
Change in medication use following treatment
Change in mean number of glaucoma medications before and after treatment
Time frame: At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36
Change in Retinal Nerve Fibre Layer (RNFL) following treatment
RNFL thickness change, measured in micrometers using optical coherence tomography
Time frame: At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36
Change in visual field (VF) following treatment
Change in VF sensitivity, measured as mean deviation in dB units using computerised VF perimetry
Time frame: At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36
Compilation of evidence for further NICE review
To provide high quality evidence of treatment efficacy upon which to base a future review of the current NICE guidance, allowing subsequent treatments to be freely used in the UK, outside the context of research
Time frame: 3 years
Compliance with NICE recommendations
To allow continued use of MPTLT in the UK, whilst complying with NICE guidance, which currently recommends treatment only in the context of research
Time frame: 3 years
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for May 2023; primary completion for Dec 2025, 31 months later.
Of 110 non-industry observational studies under Glaucoma, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 208. This study's planned 31 months is below that.
Counting every sponsor, half of 134 studies reached it within 31 months; a quarter within 12 and three quarters within 208.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Imperial College Healthcare NHS Trust